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Peritoneal Closure Versus Non Closure During Open Appendectomy

Peritoneal Closure Versus Non Closure During Open Appendectomy: a Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02803463
Enrollment
112
Registered
2016-06-17
Start date
2016-06-30
Completion date
2016-12-31
Last updated
2016-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Appendicitis

Keywords

peritoneal closure, appendectomy, postoperative pain, life quality

Brief summary

There has been no consensus over closure versus non closure of peritoneum during abdominal operations. The aim of this study is to compare the effect of peritoneal closure versus non closure over postoperative pain, early complications and life quality.

Detailed description

There has been no consensus over closure versus non closure of peritoneum during abdominal operations. in literature, few reports suggested that peritoneal closure may prolong the operation time, may increase the costs and has a probable aggravating effect on postoperative pain. In addition, there have been some reports that suggest non closure of peritoneum may not increase the postoperative complications. The need of further studies to clarify the effect of peritoneal closure versus non closure on postoperative pain and life quality especially has been specified in some literature. The aim of this study is to compare the effect of peritoneal closure versus non closure over postoperative pain, early complications and life quality.

Interventions

PROCEDUREopen appendectomy with peritoneal closure

open appendectomy with peritoneal closure under general anesthesia for acute appendicitis

PROCEDUREopen appendectomy without peritoneal closure

open appendectomy without peritoneal closure under general anesthesia for acute appendicitis

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* patients with acute appendicitis * age between 18-65 years

Exclusion criteria

* preoperatively diagnosed intraabdominal abcess * intraoperatively diagnosed free purulent fluid in abdominal cavity * pregnancy * malignancy history * mental retardation * chronical renal failure * chronical liver disease * diabetes mellitus * patients' denial of participation to study

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue pain scorepostoperative day 1visual analogue score for pain at postoperative day 1 via using 10 cm vas scale.
Surgical Site Infectionpostoperative 30 daysPostoperative Surgical Site Infection in 30 days following surgery includes incisional infections and intrabdominal abcess
Life Quality Scorepostoperative day 10Euro-Qol 5D-5L for assesment of life quality at postoperative day 10th

Secondary

MeasureTime frameDescription
operation timeintraoperativelytime from beginning of incision to closure of incision
wound dehiscencepostoperative 30 daysfascial dehiscence during postoperative 30 days diagnosed via physical examination of sonography.
postoperative mortalitypostoperative 30 daysmortality in postoperative 30 days

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026